Zylet vs TobraDex in Blepharokeratoconjunctivitis

• ClinicalTrials.gov Identifier: NCT00447577
• Recruitment Status: Completed
• First Posted: March 14, 2007
• Last Update Posted: December 9, 2011
• Sponsor: Bausch & Lomb Incorporated
• Information provided by (Responsible Party): Bausch & Lomb Incorporated

Study Description

Brief Summary:

The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis

Condition or disease	Intervention/treatment	Phase
Blepharokeratoconjunctivitis	Drug: Loteprednol etabonate and tobramycin ophthalmic suspension; Drug: Tobramycin and dexamethasone ophthalmic suspension	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 276 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Clinical Safety and Efficacy Evaluation of Zylet (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension) vs. Tobradex (Tobramycin and Dexamethasone Ophthalmic Suspension) in the Treatment of Blepharokeratoconjunctivitis
• Study Start Date: January 2007
• Actual Primary Completion Date: June 2007
• Actual Study Completion Date: June 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: Zylet; Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (Zylet)	Drug: Loteprednol etabonate and tobramycin ophthalmic suspension; Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
Active Comparator: Tobradex; Tobradex (tobramycin and dexamethasone ophthalmic suspension, 0.3%/0.1%), US marketed product (Alcon) from commercial lots.	Drug: Tobramycin and dexamethasone ophthalmic suspension; Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

Outcome Measures

Primary Outcome Measures :

1. The primary efficacy endpoint for this study is the change from baseline to Day 15 in the signs and symptoms composite score [ Time Frame: 15 days ]

Secondary Outcome Measures :

1. The distribution of Investigator global assessment at each visit. [ Time Frame: Visit 2, 3 & 4 ]
2. The percentage of eyes that were considered improved or cured at each visit based on the Investigator global assessment. [ Time Frame: Visit 2, 3 & 4 ]
3. The change from baseline to Day 7 (Visit 3) and to Day 3 (Visit 2) in the signs and symptoms composite score. [ Time Frame: Visit 2 & 3 ]
4. The change from baseline to each visit in the signs composite score and the symptoms composite score. [ Time Frame: Visit 1, 2, 3 & 4 ]
5. The change from baseline to each visit in the Blepharitis signs composite score, the conjunctivitis signs composite score, and the Keratitis signs composite score. [ Time Frame: Visit 1, 2, 3 & 4 ]
6. The change from baseline to each visit in individual signs and symptoms. [ Time Frame: Visit 1, 2, 3 & 4 ]
7. VA, Biomicroscopy, and IOP assessments at each visit [ Time Frame: Visit 1, 2, 3 & 4 ]
8. Adverse Events [ Time Frame: Visit 1, 2, 3 & 4 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Must be at least 18 years of age
• Must be able and willing to comply with all treatment and follow up procedures
• Must have the ability to understand and sign an Informed Consent Form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization
• Must be able to self-administer drugs
• Must have a clinical diagnosis of blepharokeratoconjunctivitis in at least one eye (total Ocular Signs and Symptoms score of at least 10, with at least one ocular sign and one ocular symptom each having a score of Grade 2 level or higher)
• Women of childbearing potential must be sexually inactive or using an approved birth control methods and must have a negative urine pregnancy test
• Must be willing to discontinue contact lens use for the duration of the study
• Must have pin-holed Snellen visual acuity equal to or better than 20/40 in both eyes

Exclusion Criteria:

• Any uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis)
• Known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids
• Use of any systemic or topical ophthalmic non-steroidal anti-inflammatory agents, analgesics, and antihistamines that cannot be discontinued during the study
• Use of any topical ophthalmic medications, including tear substitutes, within 2 hours before and that cannot be discontinued during the study
• Use of any systemic or topical ophthalmic antibiotic agents within 72 hours before and that cannot be discontinued during the study
• Use of any systemic or topical ophthalmic corticosteroid agents within 7 days before and that cannot be discontinued during the study
• Use of any systemic or topical ophthalmic mast cell stabilizers within 14 days before and that cannot be discontinued during the study
• Use of any topical ophthalmic immunosuppressant (e.g. Restasis) agents within 30 days before and that cannot be discontinued during the study
• Suspected preseptal cellulites, or any other disease conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug
• Suspected dacrocystitis
• Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study
• Ocular surgery (including laser surgery) in either eye within the past 3 months

Contacts and Locations

Locations

United States, North Carolina

Cornerstone Eye Care

High Point, North Carolina, United States, 27262

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators

• Study Director: Timothy Comstock, OD; Bausch & Lomb Incorporated

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

White EM, Macy JI, Bateman KM, Comstock TL. Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. Curr Med Res Opin. 2008 Jan;24(1):287-96.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00447577 History of Changes
• Other Study ID Numbers: 512
• First Posted: March 14, 2007
• Last Update Posted: December 9, 2011
• Last Verified: December 2011

Additional relevant MeSH terms:

Loteprednol Etabonate; Tobramycin; Tobramycin, Dexamethasone Drug Combination; Dexamethasone; Dexamethasone acetate; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Allergic Agents; Ophthalmic Solutions; Pharmaceutical Solutions